My Midlands based client has a contract for a Head of Quality Engineering and Validation:
Responsible for CAPA, Calibration, Validation, Documentation Control and Complaint Handling
1. Overall control of the plant CAPA system to include review, entry, monitor for closure and issuance of monthly updates
2. Overall responsibility for the plant Calibration Program.
3. Overall responsibility for the Plant Validation Program
4. Preliminary approval on all internal validation protocols/test reports prior to release to Senior Management.
5.Perform process capability studies/statistical studies where required.
6.Responsible for overall co-ordination of document control to include the Quality Manual, Policy and Functional SOPs and the Device Master Record System.
7.Issuance of monthly report and trending charts relating to all change control both permanent and temporary i.e. all ECO’s.
8.Maintain the current master index for all plant parameter sheets.
9.Complaint investigation, response and trending.
10. Overall co-ordination and control of complaint
11. Complete project work as required by Supervisor or other management personnel
12. Internal auditing within the plant.
13. Act as in-house co-ordinator for all external standards (vertical and horizontal), guidance documents etc
14. Ensure that risk management is completed throughout product realisation
15. Act as functional deputy for the QA Manager.
16. Ensure compliance with relevant Company and Corporate requirements and legislation
Supervision of 2 QA Analysts, 1 Validation Engineer, 1 Calibration Engineer and 1 Quality Engineer
Third level qualification in a science/engineering related discipline.
5 years QC/QA experience in a medical device or related industry
Salary dependent on experience
To take advantage of this opportunity call Tanya on (090)6493882 and send your cv
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